Relacorilant Medicine 03 June 2025 Extended indication Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer Therapeutic value No estimate possible yet Total cost € 5,226,000.00 Registration phase Registration application pending Product Active substance Relacorilant Domain Oncology Reason of inclusion New medicine (specialité) Main indication Ovarian cancer Extended indication Treatment of adult patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Corcept Portfolio holder Mechanism of action Route of administration Oral Therapeutical formulation Capsule Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Selectieve glucocorticoïde receptorantagonist. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP No Submission date October 2025 Expected Registration November 2026 Orphan drug Yes Registration phase Registration application pending Reimbursement Medicine sluice Additional remarks Tijdslijn op basis van IHSI-inschatting. Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation De fase 3 studie loopt nog. Het eindpunt van de fase 3 studie is onzeker (PFS in plaats van OS). Duration of treatment Frequency of administration 1 times a day Dosage per administration 150mg References NCT05257408 (ROSELLA) Additional remarks Expected patient volume per year Patient volume < 130 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References GIPdatabank Additional remarks Volgens declaratiedata waren er in 2022 ongeveer 130 gebruikers van middelen voor platinum-resistente eierstok-, tuba-, en eileidercarcinoom. Expected cost per patient per year Cost € < 40,200.00 This amount gives an indication of the total cost. It is the result of the average expected patient volume times the average cost per patient. both per year. References Medicijnkosten.nl Additional remarks Er is nog niets bekend over de mogelijke kosten in Nederland. Dit middel is ook in ontwikkeling voor het syndroom van Cushing. Uitgaande van de prijs van een vergelijkbaar middel voor het syndrooom van Cushing (osilodrostat) (€119,78 inclusief BTW voor 10mg) kan een schatting gemaakt worden (1). Een jaarlijkse behandeling kost dan €40.136,19 per patiënt per jaar (exclusief BTW, €119,78/1,09*365,24). Potential total cost per year Total cost € 5,226,000.00 Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks